Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example SubstanceDefinition: Drug Substance Nomenclature and Structure

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "21b6b724-507e-4cf4-a462-93334b98d166"

Profile: Substance General Information

identifier: levoThyroxine

classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)

manufacturer: urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501

supplier: urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b

MolecularWeights

-Amount
*798.85 u (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C41127 = 'u')

structure

technique: NMR Spectroscopy ()

representation

type: InChI File (small molecule) (PQ-CMC-FDA Temporary Codes#C54683)

representation: YDTFRJLNMPSCFM-YDALLXLXSA-M

representation

type: SMILES (PQ-CMC-FDA Temporary Codes#C54684)

representation: [Na+].N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C([O-])=O

representation

document: urn:uuid:d94ad7ac-b935-432f-bc68-312b6b8dcca7

representation

document: urn:uuid:22bd989e-8056-494f-9bc1-195d13428179

Codes

-Code
*054I36CPMN (Unique Ingredient Identifier (UNII)#054I36CPMN)

name

name: LEVOTHYROXINE SODIUM ANHYDROUS

type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)

preferred: true

name

name: sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate

type: IUPAC Name (PQ-CMC-FDA Temporary Codes#C203356)

name

name: 55-03-8

type: CAS Number (PQ-CMC-FDA Temporary Codes#C54682)

Relationships

-SubstanceDefinition[x]Type
*urn:uuid:832f22b4-6f0c-41f8-9b7d-f26f55e9973cPolymorph ()